Inside Health Policy, for its FDA Week article “Cures Bill Keeps Software Used In Blood Transfusions Under FDA Oversight,” quoted Akin Gump health care and life sciences partner Nathan Brown on the revised language in the 21st Century Cures bill concerning the regulation of health software, which unanimously passed the House Energy and Commerce Committee. The health software provisions in the 21st Century Cures bill derive from the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act. One of the last changes made to these provisions was to provide more clarity on what constitutes “health software,” which is not to be regulated as a medical device under the SOFTWARE Act. The final bill language specifically clarifies that blood-related software does not constitute “health software.”

Brown explained that not carving out the blood-related software might have created confusion within the blood products industry. Although these software applications share many attributes with health software as defined in the bill, they are currently regulated by the FDA’s biologics center as medical devices. Their status would not change under the bill language.

Brown added that the SOFTWARE Act has progressed since its initial draft, saying, “The staff has worked hard to have a lot of voices at the table. It’s really evolved through input from a lot of different sources that will give a lot of technology industry groups more comfort.”